WASHINGTON — The company responsible for a global recall of sleep apnea machines will be barred from resuming production at U.S. facilities until it meets a number of safety requirements, under a long-awaited settlement announced Tuesday by federal officials.
Philips will be required to overhaul its manufacturing and quality control systems and hire independent experts to vet the changes, according to a court order announced by the U.S. Department of Justice. The company must also continue to replace, repair, or provide refunds to all U.S. customers who got the defective devices, the department said.
The action is a major step toward resolving one of the biggest medical device recalls in history, which has dragged on for nearly three years.
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